Merck Sharp & Dohme B.V. v. Warner Chilcott Company LLC et al
MEMORANDUM OPINION. Signed by Judge Gregory M. Sleet on 8/26/2016. (mdb)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
MERCK SHARP & DOHME B.V.,
WARNER CHILCOTT COMPANY, LLC and
WARNER CHILCOTT (US), LLC
Civil Action No. 13-2088-GMS
In this patent infringement action, plaintiff Merck Sharp & Dohme B.V. ("Merck") alleges
that a pharmaceutical product propos.ed by defendants Warner Chilcott Company, LLC and Warner
Chilcott (US), LLC (collectively "Warner Chilcott") infringe the asserted claims of U.S. Patent No.
5,989,581. (D.I. 1.) The court held a four-day bench trial in this matter on January 19 through
January 22, 2016. Presently before the court are the parties' post-trial proposed findings of fact and
conclusions oflaw concerning the validity of the patent-in-suit. (D.I. 140-141.)
Pursuant to Federal Rule of Civil Procedure 52(a), and having considered the entire record
in this case and the applicable law, the court concludes that (1) the asserted claims of the '5 81 patent
are not invalid as anticipated under 35 U.S.C. § 102(b); (2) the asserted claims of the '581 are
invalid as obvious under 35 U.S.C. § 103; and (3) each of the parties' Rule 52(c) motions are granted
in part and denied in part. These findings of fact and conclusions of law are set forth in further
FINDINGS OF FACT 1
Plaintiff Merck Sharp & Dohme B.V. ("Merck") is a corporation organized and
existing under the laws of the Netherlands with its principal place of business at Waarderweg 39,
Haarlem, Netherlands 2031 BN. (D.I. 1.)
Plaintiff is a wholly owned subsidiary, through intervening affiliated companies, of
Merck & Co., Inc., a Delaware corporation. (D.I. 1.)
Warner Chilcott Company LLC is a limited liability company organized and existing
under the laws of Puerto Rico, having a place of business at Union Street, Road 195, Km 1.1,
Fajardo, Puerto Rico 00738-1005. (D.I. 11.)
Warner Chilcott (US), LLC is a limited liability company organized and existing
under the laws of Delaware, having a place of business at 100 Enterprise Drive, Suite 280,
Rockaway, New Jersey 07866. (D.I. 11.)
Warner Chilcott Company LLC and Warner Chilcott (US) LLC are collectively
referred to herein as "Warner Chilcott" or "Defendants."
The court has subject matter jurisdiction, as well as personal jurisdiction over all
Organon USA Inc., a company affiliated with the Plaintiff, holds an approved New
Drug Application ("NDA") No. 21-187, under Section 505(a) of the Federal Food, Drug and
Cosmetic Act ("FFDCA"), 21 U.S.C. § 355(a), for ethinyl estradiol and etonogestrel vaginal ring,
0.015 mg/day and 0.12 mg/day, which is sold under the trade name NuvaRing. (D.I. 1.)
NuvaRing was approved by the FDA in October 2001 as a contraceptive and is
indicated for the prevention of pregnancy.
Prior to trial, the parties submitted an exhibit of uncontested facts in conjunction with their Pretrial
Order. (D.I. 110, Ex. A.) The court takes most of its findings of fact from the parties' uncontested facts.
Where necessary, the court has overruled objections to the inclusion of these facts_. The court has also
reordered and renumbered some paragraphs, corrected some spelling and formatting errors, and made minor
edits for the purpose of concision and clarity that it does not believe alters the meaning of the paragraphs
from the Pretrial Order. Otherwise, any differences between this section and the parties' statement of
uncontested facts are unintentional.
The court's findings of fact with respect to matters that were the subject of dispute between the
parties are included in the Discussion and Conclusions of Law section of this opinion, preceded by the phrase
"the court finds" or "the court concludes."
The Plaintiff and its corporate predecessors have been marketing and selling
NuvaRing since 2002.
The active pharmaceutical ingredients of NuvaRing are etonogestrel, a
progestogenic steroid, and ethinyl estradiol, an estrogenic steroid.
The '581 patent is currently listed the Orange Book with respect to NuvaRing.
The current NuvaRing prescribing information states that NuvaRing "is a nonbiodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive
vaginal ring containing two active components, a progestin, etonogestrel (13-ethyl-l 7-hydroxy-11methylene-18,19-dinor-l 7a-pregn-4-en-20-yn-3-one) and an estrogen, ethinyl estradiol (19-nor17a-pregna-l,3,5(10)-trien-20-yne-3,l 7-diol). When placed in the vagina, each ring releases on
average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week
period of use."
U.S. Patent No. 5,989,581 ("the '581 patent"), which is entitled "Drug Delivery
System for Two or More Active Substances" and lists Rudolf Johannes Joseph Groenewegen as the
sole inventor, issued on November 23, 1999.
The '581 patent issued from U.S. Patent Application No. 09/056,700, filed in the
United States Patent and Trademark Office ("USPTO") on April 8, 1998.
U.S. Patent Application No. 09/056,700 purports to claim priority to European
Patent Office Application No. 97/201,098 ("the '098 application"),. filed on April 11, 1997.
The '581 patent is assigned to Akzo Nobel N.V.
According to FDA's "Approved Drug Products with Therapeutic Equivalence
Evaluations" (the "Orange Book"), the '581 patent expires on April 8, 2018.
The Asserted Claims
The claims of the '581 patent that are asserted in this action are 2--4 and 8-11.
Claim 2 of the '581 patent recites: "A drug delivery system according to claim 1,2
wherein the delivery system has a substantially ring-shaped form and is intended for vaginal
administration of the mixture of the progestogenic and estrogenic compounds."
Claim1 ofthe '581 patent recites:
A drug delivery system comprising at least one compartment which comprises a
thermoplastic polymer core and a thermoplastic polymer skin covering the core, said core
comprising a mixture of a steroidal progestogenic compound and a steroidal estrogenic
compound in a ratio by weight that allows a direct release of both said progestogenic
compound and said estrogenic compound in physiologically required amounts, said
Claim 3 of the '581 patent recites: "A drug delivery system according to claim 1,
wherein at least the skin material comprises ethylene-vinyl acetate copolymer as the thermoplastic
Claim 4 of the '581 patent recites: "A drug delivery system according to claim 1,
wherein the amount of progestogenic compound dissolved in the thermoplastic core material is 2
to 5 times the amount necessary for obtaining saturation concentration."
Claim 6 of the '581 patent recites:
A drug delivery system according to claim 5, 3 wherein the thermoplastic
polymer used for the core material is an ethylene-vinylacetate copolymer,
the thermoplastic polymer used for the skin material is an ethylenevinylacetate copolymer, the thermoplastic polymer used for the skin
material is an ethylene-vinylacetate copolymer, said core comprising a
mixture of a progestogenic compound etonogestrel and an estrogenic
compound ethinyl estradiol in a ratio of 10 parts to 2-4 parts, said core
comprising from 0.3 up to about 1% by weight of etonogestrel and from
about 0.05 to about 0.3% by weight of ethinyl estradiol.
Claim 8 of the '581 patent recites: "A drug delivery system according to claim 6,
characterised in that the skin is an ethylene-vinylacetate copolymer skin having a thickness ranging
from 40 to 300 µm and a vinylacetate content ranging from 5 to 15%."
Claim 9 of the '581 patent recites: "A drug delivery system according to claim 8,
characterised in that the skin thickness.is 80 to 150 µm and the vinyl acetate content is 9-10%."
progestogenic compound being initially dissolved in said polymer core material in a degree
of super saturation of 1 to about 6 times of the amount by weight necessary for obtaining
saturation concentration of said progestogenic compound in said polymer core material at
25 °C, said estrogenic compound being dissolved in said polymer core material in a
concentration lower than that of said progestogenic compound, and said thermoplastic skin
being permeable for said progestogenic and estrogenic compounds.
Claim 5 of the '581 patent recites:
A drug delivery system in a substantially ring-shaped form and suitable for vaginal
administration comprising at least one compartment which comprises a thermoplastic
polymer core and a thermoplastic polymer skin covering said core, said core comprising a
mixture of a progestogenic steroidal compound and an estrogenic steroidal compound in a
ratio by weight of 10 parts of the progestogenic compound to 1.5-5 parts of the estrogenic
compound, said progestogenic compound being initially dissolved in said polymer core in
a degree of supersaturation of 1 to about 6 times of the amount by weight necessary for
obtaining saturation concentration of said progestogenic compound in said polymer core
material at 25° C., and said polymer skin being permeable for both the progestogenic and
the estrogenic compounds.
Claim 10 of the '581 patent recites: "A drug delivery system according .to claim 5,
wherein the core material is comprised of an ethylene-vinylacetate copolymer with a 25 to 35%
vinyl acetate content."
Claim 11 of the '581 patent recites: "A drug delivery system according to claim 5,
wherein the core material comprises 0.55 to 0.8% by weight of etonogestrel and 0.12 to 0.18% by
weight of ethinyl estradiol."
On February 24, 2014, the court ordered the parties' stipulation that no construction
was necessary for the term "said progestogenic compound being initially dissolved in said polymer
core." (D.I. 93.)
On February 25, 2016, the court construed the term "physiologically required
amount" to mean "the amounts of the progestogenic compound and the estrogenic compound
required by the body to achieve the full therapeutic effect."
Warner Chilcott's ANDA
Warner Chilcott filed Abbreviated New Drug Application ("ANDA") No. 204305
("Warner Chilcott's ANDA") under Section 505G) of the FFDCA to the FDA, seeking approval to
market and sell a generic ethinyl estradiol and etonogestrel vaginal ring ("Warner Chilcott's ANDA
Product") prior to the expiration of the '581 patent.
Warner Chilcott's ANDA contains a certification, pursuant to 21 U.S.C. §
355G)(2)(a)(vii)(IV), alleging that the '581 patent is invalid, unenforceable, and/or will not be
infringed by the activities described in Warner Chilcott's ANDA.
No earlier than November 6, 2013, Warner Chilcott sent written notice of its ANDA
certification relating to the '5 81 patent to Plaintiff, informing Plaintiff that Warner Chilcott seeks
approval to market its ANDA Product before the expiration of the '581 patent.
Warner Chilcott's ANDA Product is a contraceptive vaginal ring containing two
active pharmaceutical ingredients, a progestogenic compound, etonogestrel, and an estrogenic
compound, ethinyl estradiol.
The proposed indication for Warner Chilcott's ANDA Product is the prevention of
For purposes of this litigation only, Warner Chilcott stipulated that its ANDA
Product would infringe, if marketed, all limitations of the asserted claims of the '581 patent. (D.I.
DISCUSSION AND CONCLUSIONS OF LAW.
The court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331,
1338, and2201. Venue is proper in this courtunder28 U.S.C. §§ 1391and1400(b). After having
considered the entire record in this case, the substantial evidence in the record, the parties' posttrial submissions, and the applicable law, the court concludes that: (1) the asserted of the '581 patent
are not invalid as anticipated under 35 U.S.C. § 102(b); (2) the asserted of the '581 are invalid as
obvious under 35 U.S.C. § 103; and (3) each of the parties' Rule 52(c) motions are granted in part
and denied in part. The court's reasoning follows.
Warner Chilcott argues that the '581 patent is anticipated by PCT '015 (JTX-30).
1. The Legal Standard
"[I]nvalidity by anticipation requires that the four comers of a single prior art document
describe every element of the claimed invention, either expressly or inherently, such that a person
of ordinary skill in the art could practice the invention without undue experimentation." Advanced
Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272, 1282 (Fed. Cir. 2000). In Verizon Services
Corp. v. Cox Fibernet Virginia, Inc., the Federal Circuit discussed the standards for inherent
[A] prior art reference may anticipate without disclosing a feature of
the claimed invention if that missing characteristic is necessarily
present, or inherent, in the single anticipating reference. However,
a patent claim cannot be anticipated by a prior art reference if the
allegedly anticipatory disclosures cited as prior art are not enabled.
The standard for what constitutes proper enablement of a prior art
reference for purposes of anticipation under section 102, however,
differs from the enablement standard under section 112. It is wellsettled that utility or efficacy need not be demonstrated for a
reference to serve as anticipatory prior art under section 102.
602 F.3d 1325, 1337 (Fed. Cir.2010) (alteration in original) (internal quotation marks and citations
A patent is presumed to be valid. 35 U.S.C. § 282. The party asserting invalidity bears the
burden of establishing invalidity by clear and convincing evidence. Microsoft Corp. v. i4i Ltd.
P'ship, 131 S. Ct. 2238 (2011).
This burden of proof remains constant, even when a patent
invalidity attack relies on the same prior art previously considered by the PTO. See Sciele Pharma
Inc. v. Lupin Ltd., 684 F.3d 1253, 1260 (Fed. Cir. 2012) ("The burden does not suddenly change to
something higher-'extremely clear and convincing evidence' or 'crystal clear and convincing
evidence'-simply because the prior art references were considered by the PTO.") Practically
speaking, however, "it may be harder to meet the clear and convincing burden when the invalidity
contention is based upon the same argument on the same reference that the PTO already
considered." Id. Whether a prior art reference anticipates a patent claim is a question of fact.
Advanced Display Sys., 212 F.3d at 1281.
2. The Parties' Contentions and Discussion
Warner Chilcott's anticipation argument is based on one prior art document, PCT '015.
PCT '015 is a patent application that was filed on July 4, 1995 by Akzo Nobel, N.V., Organon's
then-parent. (JTX-30.1.) One of the inventors of PCT '015, Mr. Groenwegen, is also the inventor
of the '581 patent. (JTX-1.1.) PCT '015 discloses a two-compartment vaginal ring composed of
polyethylene vinyl acetate with 28% vinyl acetate ("PEVA 28"). (Tr. 160:11-162:5 (Kiser).) The
first compartment contains a progestogenic compound, etonogestrel ("ETO"), and the second
compartment contains a mixture of ETO and an estrogenic compound, ethinyl estradiol ("EE").
(JTX-30.10.) The target release rates for the PCT '015 ring are 90-150 µg/day ETO and 10-20
µg/day EE. (JTX-30.6 at 26-68.) For the second compartment, PCT '015 discloses a preferred
range of 0.05-3% w/w EE and 0.05-5% ETO. (JTX-30.6 at 20-24.) PCT '015 also discloses that
the lengths of the compartments can be adjusted, such that the "[r]atios of the lengths of the first
and second compartment are contemplated to be between 30:1 and 1:30 .... " (JTX-30.5 at 22-24.)
The parties do not dispute that PCT '015 discloses several of the asserted limitations,
including the same polymer and steroids claimed by the '581 patent. The court therefore focuses
on the claim terms in dispute: (1) supersaturated progestin; (2) physiologically required amounts;
(3) a lower concentration of estrogen than progestin; and (4) fixed ratios and concentrations of
estrogen and progestin. The court addresses each in turn.
All of the asserted claims of the '581 patent require a supersaturated progestogenic steroid.
Claims 2, 3, and 8-11 of the '5 81 patent require supersaturation "from) to about 6 times of the
amount by weight necessary for obtaining saturation concentration of said progestogenic compound
in said polymer core material at 25 °C." '581 patent at 7:37--41. Claim 4 requires 2-5 degrees of
supersaturation. The parties stipulated that saturation concentration ofETO in PEVA 28 is 0.35%
w/w. (D.I. 136 at if 3.) Therefore, the claimed levels of supersaturation are 0.35% to 2.1 % w/w for
claims 2, 3, and 8-11 (Tr. 150:14-21 (Kiser)), and 0.7% to 1.75% w/w for claim 4 (Tr. 183:12-25
The parties dispute whether PCT '015 discloses a progestogenic compound dissolved at a
Although PCT '015 never explicitly mentions supersaturation,
Warner Chilcott argues that it inherently discloses supersaturated ETO.
As support, Warner
Chilcott points to Example 2, which describes rings with ETO concentrations between 0.45% and
0.8% w/w in PEVA 28. (JTX-30.10.) This falls within the claimed ranges. Merck responds that
Example 2 only discloses supersaturation if the ETO in that example is fully dissolved. (Tr. 165 :2-
23 (Kiser).) Just as PCT '015 does not mention supersaturation, it does not mention whether the
ETO in the second compartment is fully dissolved. Warner Chilcott's expert, Dr. Kiser, testified
that if crystals were visible in the compartment, it would indicate the compound was not fully
(Tr. 165:13-23 (Kiser).)
PCT '015 discloses crystalline progestogen in the first
compartment (JTX-30.5 at 19-20), but it does not mention the presence of crystals in the second
compartment. The court finds that this supports a strong inference that the ETO in the second
compartment was fully dissolved. Further, Warner Chilcott notes that the manufacturing conditions
for Example 2 of PCT '015 are the same as for several examples in the '581 patent. (Compare
JTX-30.6-7 and JTX-30.10 with JTX-1.5-6, Exs. 1, 2, 4, and 5). The '581 patent discloses that all
of the ETO is fully dissolved. Contrary to the Merck's assertions, the court finds no reason to
presume that the ETO in Example 2 of PCT '015 is not fully dissolved. Accordingly, the court
concludes that PCT '015 inherently discloses the supersaturated progestin limitation.
Physiologically Required Amounts
Claims 2-4 of the '581 patent require one compartment to release the progestogenic and
estrogenic compound "in physiologically required amounts." (JTX-1.6 at 7:30-36.) The court
construed this term to mean "the amounts of the progestogenic compound and the estrogenic
compound required by the body to achieve the full therapeutic effect." (D.I. 138 at 2.) For PCT
'015 to disclose this limitation, the second compartment must be capable of releasing ETO and EE
in amounts required to achieve contraception.
Warner Chilcott's theory for how PCT '015 meets this claim limitation proceeds as follows.
First, the second compartment in PCT '015 is "structurally and chemically identical" to the
compartment in asserted claims 2-4. (D.I. 141 at 19). Merck does not dispute this point. Second,
PCT '015 expressly lists the physiologically required amounts for contraception: at least 90 µg/day
ofETO and 10 µg/day of EE. (JTX-30.6 at 26-28.) Third, the concentration ranges disclosed for
the second compartment (0.05%-3% w/w ETO and 0.05-5% w/w EE) encompass the
concentrations used in NuvaRing (0.69% w/w ETO and 0.15% w/w EE). (See D.I. 141 at 20.)
Fourth, PCT '015 discloses that the "lengths of the compartments of the ring-shaped device are
chosen to give the required performance," and the second compartment can be up to 97% of the
length of the ring.
(See JTX-30.5 at 22-24 ("Ratios of the lengths of the first and second
compartment are contemplated to be between 30:1 and 1:30....").) Therefore, Warner Chilcott
reasons, "[a] mixed compartment that is 97% of the length of the ring and has the same
concentrations of ETO and EE as NuvaRing is essentially the same thing as NuvaRing and -will
thus certainly release 'physiologically required amounts."' (D.I. 141 at 20-21.)
Merck argues that Warner Chilcott has failed to produce sufficient evidence to prove that
PCT '015 anticipates this claim term. Merck notes that PCT '015 discloses two-compartment rings
in which-both compartments work together to deliver the physiologically required amounts of
progestogenic and estrogenic compounds. PCT '015 lists the preferred steroidal release rates for
only the ring as ·a whole, not for each separate compartment. (JTX-30.6 at 26-27.) It does not
disclose the amount of ETO released from second compartment. Therefore, Merck contends, it
does not disclose that the second compartment can release the physiologically required amounts of
ETO and EE. Merck further argues that Warner Chilcott failed to adduce testimony that if the
second compartment were lengthened, it would release the required amount of progestin. 4 (D.I.
140 at 10.)
Dr. Kiser began to opine that the lengths of the two compartments in PCT '015 could be adjusted in order to meet
this claim limitation. The court struck this portion of the testimony because it was outside the scope of his expert
report. (Tr. 178:11-180:21 (Kiser).)
The court agrees with Merck. The '581 patent discloses "at least one compartment," so the
existence of the first compartment in PCT '015 containing pure ETO does not automatically prevent
it from meeting this limitation. But PCT '015 must still disclose that the second compartment can
release ETO and EE at rates sufficient to cause contraception. Warner Chilcott may very well be
correct that modifying the PCT '015 examples such that the second compartment comprises 97%
of the ring would lead the second compartment release physiologically required amounts of ETO
and EE. But the record lacks clear and convincing evidence to support that conclusion. There is
no testimony that PCT '015 discloses an embodiment in which the second compartment would
release sufficient ETO and EE. In short, attorney argument is nofproof. ·PCT '015 does not disclose
the "physiologically required amounts" limitation.
More Progestin than Estrogen
Claims 2--4 of the '581 patent require the estrogenic compound to be dissolved "in a
concentration lower than that of [the] progestogenic compound." '581 patent at 7:41--43. Warner
Chilcott argues that PCT '015 discloses a second compartment with more progestin than estrogen.
As support, it points to the broad ranges for the "most preferred ring-shaped device of the
invention," which includes 0.05%-3% w/w ETO and 0.05%-5% w/w EE. (JTX-30.6 at 20-24.)
From these ranges, a person of skill could fashion a ring which contains more ETO than EE (for
example, 3% ETO and 2% EE).
Merck responds that none of the examples in PCT '015 disclose a second compartment with
more progestin than estrogen. Moreover, the examples indicate that the first compartment would
provide the ring with the majority of the required progestin. Therefore, Merck argues, PCT '015
does not contemplate a second compartment that includes more progestin than estrogen. Merck
also notes that in PCT '015's most preferred embodiment, the second compartment is loaded with
0.25-0.5% w/w of ETO and 0.75-1.5% w/w of EE.
(JTX-30.6 at 23-24.)
embodiment does not permit the second compartment to contain more ETO than EE. Consequently,
Merck contends that the broad ranges of preferred concentrations do not qualify as a disclosure of
using more progestin than estrogen in the second compartment.
In response, Warner Chilcott notes that a prior art "reference need not always include an
express discussion of the actual combination to anticipate." Blue Calypso, LLC v. Groupon, Inc.,
815 F.3d 1331, 1344 (Fed. Cir. 2016). The court agrees. The listed examples are not exhaustive,
nor do they limit the scope disclosed of the reference. Nothing in PCT '015 states that the second
compartment cannot have more progestin than estrogen. Therefore, a person of skill in the art
would be free to select from the broad ranges a higher concentration of progestin than estrogen, as
disclosed, if it were necessary for the ring design. The court concludes that PCT '015 discloses the
limitation of a higher concentration of pro gestin than estrogen.
Ratios and Concentrations of Progestin and Estrogen
Claims 8-11 require specific ratios and drug concentrations between the progestogenic and
estrogenic compounds. Claims 8 and 9 require ETO and EE "in a ratio of 10 parts to 2--4 parts," at
concentrations of 0.3-1 % w/w ofETO and 0.05-0.3% w/w EE. (JTX-1.6 at 8:28-32.) Claims 10
and 11 require "a ratio by weight of 10 parts of the progestogenic compound to 1.5-5 parts of the
estrogenic compound." (JTX-1.6 at 8:10-12.) Claim 11 further requires 0.55-0.8% w/w ETO and
0.12%-0.18% w/w EE. (JTX-1.6 at 8:47--49.) PCT '015 discloses broad concentration ranges of
0.05-3% w/w ETO and 0.05-5% w/w EE. (JTX-30.5 at 23-24.) During his testimony, Dr. Kiser
used the claim language of the '581 patent to show that asserted ratios could be obtained from the
ranges disclosed in PCT '015. (Tr. 188:23-190:15, 191:17-195:12 (Kiser).) Merck argues that
this was improper hindsight use of the '581 patent. The court agrees. PCT '015 does not disclose
the specific ratios and concentrations in the asserted claims.
Warner Chilcott has not met its burden to prove the asserted claims are anticipated by PCT
'015. Although PCT '015 disclosed the requirements for supersaturated progestin and more
progestin than estrogen, the evidence at trial failed to establish disclosure of other limitations. For
claims 2-4, PCT '015 did not disclose release of ETO and EE in "physiologically required
For claims 8-11, PCT '015 did not disclose the claimed specific ratios and
concentrations. For these reasons, the court concludes that none of the asserted claims are invalid
Warner Chilcott challenges the validity of each of the asserted claims of the '581 patent as
obvious in light of the prior art. The court finds, for the reasons that follow, that Warner Chilcott
has established by clear and convincing evidence that the patents-in-suit are obvious.
1. The Legal Standard
35 U.S.C. § 103(a) provides that a patent may not be obtained "if the differences between
the subject matter sought to be patented and the prior art are such that the subject matter as a whole
would have been obvious to a person having ordinary skill in the art." 35 U.S.C. § 103(a).
Obviousness is a question of law that is predicated on several factual inquires. See RichardsonVicks v. Upjohn Co., 122 F.3d 1476, 1479 (Fed. Cir. 1997). Specifically, the trier of fact is directed
to assess four considerations: (1) the scope and content of the prior art; (2) the level of ordinary
skill in the art; (3) the differences between the claimed subject matter and the prior art; and (4)
secondary considerations of non-obviousness, such as commercial success, long felt but unsolved
need, failure of others, acquiescence of others in the industry that the patent is valid, and unexpected
results. See Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
A party seeking to challenge the validity of a patent based on obviousness must demonstrate
by "clear and convincing evidence" that the invention described in the patent would have been
obvious to a person of ordinary skill in the art at the time the invention was made. As discussed
above, this burden of proof remains constant, even when a patent invalidity attack relies on the
same prior art previously considered by the PTO; still, "it may be harder to meet the clear and
convincing burden when the invalidity contention is based upon the same argument on the same
reference that the PTO already considered." See Sciele Pharma, 684 F.3d at 1260. Importantly, in
determining what would have been obvious to one of ordinary skill in the art, the use of hindsight
is not permitted. See KSR Int'l Co. v. Teleflex, Inc .., 550 U.S. 398, 421 (2007) (cautioning the trier
of fact against "the distortion caused by hindsight bias" and "arguments reliant upon ex post
reasoning" in determining obviousness). In KSR, the Supreme Court rejected the rigid application
of the principle that there should be an explicit "teaching, suggestion, or motivation" in the prior
art, the nature of the problem, or the knowledge of a· person having ordinary skill in the art, in order
to find obviousness. See KSR, 550 U.S. at 415. The KSR Court acknowledged, however, the
importance of identifying "a reason that would have prompted a person of ordinary skill in the
relevant field to combine the elements in the way the claimed new invention does in an obviousness
determination." Takeda Chem. Indus. v. Alphapharm Pty. Ltd., 492 F.3d 1350, 1356-57 (Fed. Cir.
2007) (quoting KSR, 550 U.S. at 418) (internal quotation marks omitted).
"Obvio-usness does not require absolute predictability of success," but rather, requires "a
reasonable expectation of success." See Medichem, S.A. v. Rolado, S.L., 437 F.3d 1157, 1165 (Fed.
Cir. 2006) (quoting In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)). To this end,
obviousness "cannot be avoided simply by a showing of some degree of unpredictability in the art
so long as there was a reasonable probability of success." Pfizer, Inc. v. Apotex, Inc., 480 F.3d
1348, 1364 (Fed. Cir. 2007). Moreover, while the Federal Circuit has noted that pharmaceuticals
can be an "unpredictable art" to the extent that results may be unexpected, it also recognizes that,
per KSR, evidence of a "finite number of identified, predictable solutions" or alternatives "might
support an inference of obviousness." See Eisai Co. Ltd. v. Dr. Reddy 's Labs. Ltd., 533 F.3d 1353,
1359 (Fed. Cir. 2008).
2. The Level of Ordinary Skill in the Art
A person of ordinary skill in the art would have at least a Master's degree in polymer
science, pharmacy, chemistry, pharmaceutics, chemical engineering, bioengineering, or a
comparable field, and :J?_ve years ofrelevant experience working with polymers. (See Tr. at 152:25153:20 (Kiser); Tr. at 469:9-23 (Freeman).)
3. Scope and Content of the Prior Art and Differences Between the
Claimed Subject Matter and the Prior Art
Warner Chilcott argues that the asserted claims are obvious, mostly in light of PCT '015.
As with anticipation, the disputed claim terms are: (1) supersaturated progestin; (2) physiologically
required amounts; (3) a lower concentration of estrogen than progestin; and (4) fixed ratios and
concentrations of estrogen and progestin. The court addresses each contested element in turn.
Warner Chilcott argues that PCT '015 discloses supersaturated ETO even though it does not
explicitly mention "supersaturation." "The inherent teaching of a prior art reference, a question of
fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613
(Fed. Cir. 1995). Pursuant to the anticipation analysis above, the court concludes that PCT '015
inherently discloses supersaturated ETO. Example 2 describes rings with ETO concentrations
within the supersaturation range, and the court finds credible Dr. Kiser's.testimony that the ETO in
the example is supersaturated.
Of course, "proof of inherent anticipation is not the same as proof of obviousness."
Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008). Merck argues that it
would not have been obvious to use supersaturated progestin because the prior art does not disclose
that a supersaturated ring would be stable for six months or longer. (Tr. 475:4-17 (Freeman).)
Merck also contends that PCT '015 teaches away from supersaturation, because it states that
"[p]articularly good release patterns are obtained when ... the second compartment is loaded with
a just saturated, and most preferably with a sub-saturated mixture of the progestogen and the
estrogen." (JTX-30.5 at 7-10.)
The court does not find this sufficient to render the supersaturation limitation non-obvious.
First, Merck does not dispute that a person of skill in the art could easily calculate the
supersaturation concentration of ETO.
(Tr. 300:1-8 (Kiser).)
With the knowledge of the
supersaturation concentration, a person of skill in the art would recognize that Example 2 of PCT
'015 discloses supersaturated ETO. Second, although PCT '015 does notteach that a supersaturated
ring would be stable, it also does not indicate that a supersaturated ring would be unstable. It is
silent on the issue. Merck does not produce any prior art indicating that such a ring loaded with
supersaturated progestin would be unstable. This therefore would not discourage a person of
ordinary skill from proceeding with a supersaturated ring. Third, although PCT '015 encourages
using a sub-saturated concentration of progestin, it does not discourage using a supersaturated
concentration (as it certainly does not discourage a person of ordinary skill from using one of its
disclosed examples). Further, it states that good release patterns may be obtained from a "just
saturated" concentration. This actually correlates to the degree of supersaturation claimed by the
'581 patent, which includes the saturation concentration. (Tr. 150:14-25 (Kiser).) Therefore, the
court concludes a person of ordinary skill would have found it obvious to load a ring with
supersaturated pro gestin.
Physiologically Required Amounts
W am er Chilcott claims that the prior art would encourage a person of ordinary skill in the
art to create a ring in which one compartment released the physiologically required amounts of each
steroid. Merck mainly argues that the "physiologically required amounts" limitation is not obvious
because the prior art teaches away from using a one-compartment ring. Because the '581 patent
also covers multiple-compartment rings, the court finds the relevant inquiry is not whether the prior
art teaches away from one-compartment rings, but whether it teaches away from loading
physiologically required amounts of progestin and estrogen into a single compartment.
Merck argues that the teachings of PCT '015 would discourage a person of ordinary skill
from loading physiologically required amounts of ETO and EE into one compartment. Dr. Kiser
agreed that the teaching of PCT '015 is "to separate out the physiologically required amounts of the
progestin and estrogen so that you could dial them up independently." (Tr. 256:5-12 (Kiser).)
According to Merck, delivering the full physiologically required amounts of progestin and estrogen
from the second compartment "would compromise the ability to use those two compartments to
independently control the release of each drug." (Tr. 491:2-7 (Freeman).)
Describing prior art one-compartment rings, PCT '015 states:
"These above-mentioned one-compartment rings have the disadvantage that, when loaded
with more than one active substance, release patterns of these substances can not be adjusted
independently. Such devices usually show sub-optimum release patterns for the different
substances, whereas it is generally preferred that all substances are released in a controlled
rate and during a similar duration of time. As a consequence the release ratio of the active
substances undergoes a change after a period of time."
(JTX-30.3 at 21-26.) This highlights the drawbacks ofloading certain one-compartment
rings "with more than one active substance." But, contrarily, PCT '015 then discloses a ring in
which one ofits compartments is loaded with more than one active substance. (JTX-30.5 at 12-14
("Preferred devices for contraceptive use have . . . a second compartment wherein the steroid
hormone is a mixture ofa progestogen and an estrogen.").) PCT '015 does not state that the second
compartment containing both ETO and EE shows "sub-optimum release patterns." PCT '015 also
does not state that the presence of progestin in the second compartment somehow undermines the
ability of a person of skill to adjust the concentrations of both drugs. If the key to PCT '015 is the
ability to independently adjust the steroidal release rates, then it must disclose that a person of skill
in the art can accomplish such an adjustment even when both steroids are loaded in the same
The court therefore finds that PCT '015 does not teach away fyom loading
physiologically required amounts of ETO and EE into the same compartment. At most, it teaches
away from replicating several failed one-compartment ring designs.
Merck points to several other prior art references that denigrate loading two drugs into a
single compartment. U.S. Patent No. 5,596,576 (JTX-37), which issued in 1986, teaches that "[t]he
simultaneous introduction of [progestin and estrogen] into one reservoir can however only purely
accidentally lead to the desired release ratio." (JTX-37.5 at 1:54-56.) Another 1986 reference also
teaches serious disadvantages of loading both steroids into a single compartment, namely "it is not
possible to adjust the ratio of the amount of steroid released, because the same rate-controlling
membrane is used for both steroids." (DTX-347.3.) These references seem to teach away from the
"physiologically required amounts" claim limitation. They both, however, predate PCT '015 by
over ten years. PCT '015 disproves these assertions by disclosing a ring in which one compartment
is loaded with two steroids. In light of PCT '015, the court concludes that these references would
not have discouraged a person of ordinary skill from loading a single compartment with
physiologically required amounts of estrogen and progestin.
Merck additionally points to the research of the Population Council, which reported in 1994
that they had abandoned their one-compartment vaginal ring due to poor steroidal release rates.
(Tr. 315:25-317:6 (Kiser).) The Population Council made two changes in response: (1) they moved
from one-compartment ring to a four compartment ring, and (2) they moved from a shell design to
a core design. (DTX-351.3.) The article does not discuss whether both changes were necessary to
"steady hormone release." (DTX-351.2.) The original ring's failure may have been caused by
loading the drugs in a single compartment, by the shell design, or by a combination of both. This
ambiguity leads the court to conclude that this prior art reference does not teach away from loading
both progestin and estrogen into a single compartment.
Having disposed of Merck's "teaching away" arguments, the court examines whether a
person of ordinary skill in the art would have been motivated to modify PCT '015 so that the second
compartment delivered the full amount of progestin and. estrogen. PCT '015 discloses a twocompartment ring in which the second compartment: (1) is loaded with both ETO and EE; (2) has
ahigher concentration ofETO than EE; and (3) comprises 97% of the ring. PCT '015 also discloses
the "physiologically required amounts" of progestin and estrogen. Dr. Kiser testified that a person
of ordinary skill would have used Fick's Law to optimize the second compartment to release these
target amounts ofETO and EE. (Tr. 219:13-220:5 (Kiser).) Fick's Law "relates the flux of a drug
to the diffusivity of the drug," and can be used to "predict the release rate of the drug from the
diffusion coefficient of the drug in the skin and the concentration of the drug in the skin." (Tr.
219:13-16 (Kiser).) It has been known for over a century. (Tr. 219:24-25 (Kiser).) This testimony
was not rebutted by Merck's expert, Dr. Freeman. In light of the prior art, the court finds that a
person of ordinary skill would have been motivated to optimize PCT '015 such that the second
compartment released physiologically required amounts ofETO and EE.
The court also concludes that a person of ordinary skill would also have been motivated to
create a one-compartment ring. 5 Dr. Kiser testified that a person of ordinary skill in the art would
have been motivated to create a one-compartment ring in order to decrease manufacturing costs.
(Tr. 225:6-19 (Kiser).) After concluding that the second compartment could release the necessary
levels of estrogen and progestin, a person of ordinary skill would have little reason to keep the first
compartment in place. In conclusion, the "physiologically required amorints" limitation is obvious
in light of PCT '015 and Fick's Law.
More Progestin than Estrogen
Merck argues that lo(;lding the second compartment with more progestin than estrogen is
incompatible with the teaching of PCT '015. In support, Dr. Freeman testified that PCT '015 only
disclosed small concentrations of ETO in the second compartment in order to "prevent any negative
effects from the direct release.of ethinyl estradiol onto the tissue." (Tr. 490:23-491 :1, 484:11-18
(Freeman).) But as the Warner Chilcott notes, PCT '015 does not indicate that this is the reason
for including progestin in the second compartment, and actually discloses an example of a second
compartment with quite high concentrations ofETO. (JTX-30.10.) Dr. Freeman, although he is an
expert in polymer science, does not have any experience with vaginal rings or studying the
physiological effects of drugs such as estrogen. (See Tr. 466:6-469:3 (Freeman).) Merck did not
offer any evidence to corroborate Dr. Freeman's statement regarding the use ofETO in the second
compartment. The court does not find it reliable or supported by the evidence in this case.
This conclusion is not required for the "physiologically required amounts" limitation to be obvious because the '581
patent also reads on multi-compartment rings.
As discussed in the anticipation analysis, the court finds that PCT '015 explicitly discloses
using a higher concentration of progestin than estrogen. Although Merck puts great emphasis on
PCT '015' s teaching about separating the two steroids in order to provide better control over the
release rate, the second compartment of PCT '015 contains both estrogen and progestin by design.
PCT '015 does not indicate that a higher concentration of progestin than estrogen in the second
compartment would undermine a person of ordinary skills' ability to reliably control the release
rate of both drugs. Accordingly, nothing in PCT '015 teaches away from loading the second
compartment with more progestin than estrogen. This limitation would have been obvious to a
person of ordinary skill in the art.
Ratios and Concentrations of Progestin and Estrogen
In light of the court's discussion regarding "physiologically required amounts," the court
also concludes it would have been obvious for a person of skill to derive the claimed ratios of
progestin and estrogen.
Dr. Kiser demonstrated that a person of ordinary skill could calculate the target loading
ratios using Fick's Law. (Tr. 219:10-224:6 (Kiser).) To solve for the ratios of ETO and EE, a
person of skill would need the target release rates and the partition coefficient. (Tr. 220:11-25
(Kiser).) PCT '015 discloses the target release rates. (Tr. 222:21-223:1 (Kiser).) Although not
disclosed in the prior art, Dr. Kiser explained that the partition ratio is "an inherent property" that
a person of ordinary skill could easily measure.
(Tr. 221:4-9 (Kiser).)
According to his
calculations, PCT '015's disclosure provides a target dose ratio of 10 parts ETO to 2.3 parts EE.
(Tr. 223:17-224:1 (Kiser).) This falls within the claimed ratios oflO parts ETO to 1.5-5 parts parts
EE (see JTX-1.6 at 8:9-12), and 10 parts ETO to 2-4 parts EE (see JTX-1.6 at 8:27-29). Merck
argues that this use of Fick's Law is inappropriate because PCT '015 discloses those target release
rates for the ring as a whole, not for the second compartment by itself. But as discussed above, the .
court concludes it would have been obvious to modify PCT '015 such that the second compartment
delivered the physiologically required amounts of ETO and EE-this corresponds to the ring's
disclosed target release rates. The court finds Dr. Kiser's ratio calculations reliable. Accordingly,
the claimed ratios would have been obvious in light of the prior art. ·
Dr. Kiser also testified that the concentrations disclosed in the '965 patent would have made
it obvious for a person of ordinary skill in the art to derive ratios and concentrations that fall within
those claimed. The '965 patent disclosed concentrations using the estrogenic compound estradiol
and the progestogenic compounds levonogestrel and norethindrone. (JTX-38.11 at 5:25-35.) Dr.
Kiser testified that the disclosed ratios overlap with the ratios of the '5 81 patent. (Tr. 215: 9-217:18
(Kiser).) Merck countered Dr. Kiser's testimony by noting that he did not take into account the
differences in potencies ofETO and EE compared to the disclosed progestins and estrogens in the
'965 patent. (Tr. 284:10-291:2 (Kiser).) The ratios disclosed in the '965 patent would read on
independent claim 5 of the '581 patent, which does not require a specific estrogen or progestin (Tr.
347:20-348:14 (Kiser)), but they would not overlap with the concentrations claimed in dependent
claims 8-11, which specifically require ETO and EE (Tr. 287:15-18 (Kiser)). Dr. Kiser also
admitted that a person of skill in the art would not use the ratios of the '965 patent because "the
information was too old by 1997." (Tr. 289:8-20 (Kiser).) The '965 patent issued on October 6,
1981, almost two decades before the '581 patent and fifteen years before PCT '015. The court finds
that a person of skill would not have relied on the disclosure of the '965 patent to determine the
Even though Warner Chilcott failed to establish the '965 patent as a guide to disclosure of
the claimed concentrations, the court finds the ranges provided by PCT '015 adequately disclose
these concentrations .. There is a complete overlap between the concentration ranges in PCT '015
and those disclosed in the '581 patent. The asserted claims require concentrations of 0.3%-1 %
w/w ETO and 0.05-0.3% w/w EE (JTX-1.6 at 8:28-32), and 0.55-0.8% ETO and 0.12-0.18% w/w
EE (JTX-1.6 at 8:47-49). Dr. Freeman agreed that "the ranges selected in the '581 patent are within
the broad ranges of progestin and estrogen listed" in PCT '015. (Tr. 544:10-14 (Freeman).) "A
prior art reference that discloses a range encompassing a somewhat narrower claimed range is
sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330
(Fed. Cir. 2003).
In order to rebut this prima facie case, Merck can establish that the claimed range "achieves
unexpected results relative to the prior art range" or show "that the prior art teaches away from the
claimed invention in any material aspect." Id. at 1330-31. Merck has not attempted to establish
either with respect to the claimed concentrations. The concentrations chosen were necessary in
order to obtain a target physiological effect, but there is no evidence that they achieved unexpected
results or that the prior art taught away from these claimed concentrations.
Groenewegen, the inventor, relied on clinicians and medical doctors to select the necessary release
(Groenewegen Dep. Tr. 58:4-60:4.) The court concludes that the claimed ratios and
concentrations were obvious.
The court concludes that all asserted claims of the '581 patent are obvious in light of PCT
4. Secondary Considerations of Non-obviousness
Merck contends that even if Warner Chilcott succeeded in presenting a prima facie case of
obviousness, that secondary considerations of non-obviousness rebut this showing. See Graham,
383 U.S. at 17-18. "Although secondary considerations must be taken into account, they do not
necessarily control the obviousness conclusion."
Pfizer, 480 F.3d at 1372.
"[a] nexus between the merits of the claimed invention and evidence of secondary considerations
is required in order for the evidence to be given substantial weight in an obviousness decision."
Muniauction, Inc. v. Thomson C01p., 532 F.3d 1318, 1327 (Fed. Cir. 2008) (alteration in original)
(quoting Ruiz v. A.B. Chance Co., 234 F.3d 654, 668 (Fed. Cir. 2000)). The court finds that Merck's
secondary considerations- commercial success, industry recognition and long-felt need, and
copying-fail to rebut a determination of obviousness.
Merck claims that NuvaRing is a commercial success. Merck's expert, Dr. Rainey, analyzed
the product's sales totals, profits, profit margins, prescriptiol). totals, prescription growth, and
market share. (Tr. 366:10-367:17 (Rainey).) Dr. Rainey testified that between 2008 and 2014, net
sales of NuvaRing reached over $4.1 billion globally and $2.4 billion in the U.S. (Tr. 367:22368:23 (Rainey).) He also testified that in that same time frame, NuvaRing generated gross profits
of over $3.8 billion globally and over $2.2 billion in the U.S., ahd a gross profit margin of about
92% for the global market and about 95% for the U.S.
(Tr. 369:7-370:18 (Rainey).) U.S.
prescription totals for NuvaRingreached over 53 million from 2002 through June 2015. (Tr. 372:7373:18 (Rainey).) Dr. Rainey testified that NuvaRing has been among the top two branded
hormonal contraceptives since 2010. (Tr. 375:12-18 (Rainey).)
The court did not find Dr. Rainey's testimony reliable. First, he did not consider sales data
from the first six years NuvaRing was on the market, even though that information was publically
available. (Tr. 396:23-397:2 (Rainey).) The 2002 annual report from Akzo Nobel, the former
parent to Organon, indicates that NuvaRing "took off slower than expected" when it was first
released in the U.S. market. (JTX-78.16, 24.) Second, Dr. Rainey did not consider the cost of
research and development or the cost of marketing in determining the profitability of NuvaRing.
(Tr. 403:16-406:5 (Rainey).) Third, Dr. Rainey also did not compare NuvaRing's product gross
margin to other oral contraceptives, or other Merck pharmaceutical products.
Fourth, Dr. Rainey only compared NuvaRing's market share to other branded
contraceptives, excluding the sales of generics from the market share of competing products. (Tr.
604:10-605:7 (McDuff).) Although the court disagrees with Dr. McDuff's assertion that the
relevant market includes contraceptive methods such as sterilization and barrier methods (Tr.
605:21-25 (McDuff)), the court concurs that the proper market for evaluating NuvaRing's success
should include all hormonal contraceptives.
When the full market of prescription hormonal
contraceptives is taken into account, NuvaRing is not the top pharmaceutical contraceptive, but the
fifth. '(Tr. 606:19-607:7 (McDuff).) The court finds that Merck has established at most a modest
level of commercial success for NuvaRing.
Commercial success is only. relevant to the non-obviousness inquiry if there is a nexus
between the success and the claims of the '581 patent. Dr. Freeman testified that there was a nexus
betWeen the claimed invention and NuvaRing' s success. He claimed the advantages of "effective
contraception and release of a progestin and estrogen at therapeutic levels over a prolong period of
time ... derive from the structure ofNuvaRing and the elements in the claims that we have been
talking about that derive from the supersaturation." (Tr. 530:4-10 (Freeman).) But effective
contraception is not a novel feature of the '581 patent. As Warner Chilcott correctly notes, those
celebrated features were already disclosed in PCT '015, which stated that the objective was "to
provide a safe ring-shaped device, with a good release pattern." (JTX-30.4 at 7-8.) The court is
not persuaded that the '581 patent's inventive features led to the success ofNuvaRing. The court
concludes that commercial success does not rebut a finding of obviousness.
Industry Recognition and Long-Felt Need
Merck also fails to show a nexus between industry recognition or long-felt need and the
Merck notes that NuvaRing won Time Magazine's 2001 award for Best
Innovation of the Year for Health. (JTX-41.) But Time's recognition of NuvaRing lacks any
connection to the patented features. The article mentions that NuvaRing is "a thin, flexible plastic
ring that women can flatten like a rubber band and insert once a month into the vagina" and it
releases "the same progestin and estrogen found in low-dose birth-control pills." (JTX-41.) PCT
'015 shares all of these features. Merck's discussion of long-felt need focuses on the need for a
hormo:qal contraceptive that is dosed once every 28 days, can be inserted and removed by the
patient, cannot be seen and does not irritate the skin, and is rapidly reversible. (Tr. 439:4-441 :5,
462:2-25 (Simon).) It may have taken "almost 30 years of industry efforts" to bring such a ring to
the market (D.I. 140 at 37), but these advantages and long-felt need are not what is inventive in the
Because there is no relationship between the inventive features and industry
recognition or long-felt need, they do not weigh in favor of a finding of non-obviousness.
Merck established that Warner Chilcott attempted several to design arouild NuvaRing, but
failed to develop any of them into a commercial product. (Muldoon Dep. Tr. 37:02-37:17; 48:0948:15, 54:25-55:17, 104:1-104:11, 115:07-12, 141:02-145:08, 149:21-150:4.) "A showing of
copying is only equivocal evidence of non-obviousness in the absence of more compelling objective
indicia of other secondary considerations" Ecolochem, Inc. v. S. California Edison Co., 227 F.3d
1361, 1380 (Fed. Cir. 2000). Further, "demonstration that a defendant has copied a patented
invention is not compelling evidence of non-obviousness in the Hatch-Waxman context due to the
unique nature of the ANDA process." Allergan, Inc. v. Watson Labs:, Inc.-Florida, 869 F. Supp.
2d 456, 485 (D. Del. 2012). Therefore, the court does not find that copying is strong objective
evidence of non-obviousness in this case. Merck has failed to rebut Warner Chilcott's prima facie
case of obviousness.
For the reasons stated above, the court concludes that: (1) the asserted claims of the '5 81
patent are not invalid as anticipated under 35 U.S.C. § 102(b); (2) the asserted claims of the '581
are invalid as obvious under 35 U.S.C. § 103; and (3) each of the parties' Rule 52(c) motions are
granted in part and denied in part.
Dated: August 1G, 2016
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